Last updated: 06/09/2025 10:10:43

Belimumab (BENLYSTA®) Pregnancy Registry

GSK study ID
114256
See study documents
Clinicaltrials.gov ID
NCT01532310
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol
Trial description: This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Birth defects

Timeframe: Up to one year after birth

Secondary outcomes:

Other pregnancy outcomes

Timeframe: At birth

Infant outcomes

Timeframe: Up to 1 year after birth

Interventions:
  • Drug: belimumab
    • Enrollment:
    77
    Primary completion date:
    2022-11-11
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Patricia Juliao, Keele Wurst, Jeanne M Pimenta, Kim Gemzoe, Helain Landy, M Anthony Moody, Hugh Tilson, Deborah Covington, Tammy Moore, Rebecca Marino, Jennifer Gilbride, Andrew Liu, Paige Meizlik, Michelle Petri. Belimumab use during pregnancy: Interim results of the belimumab pregnancy registry. Birth Defects Res. 2022; DOI: 10.1002/bdr2.2091 PMID: 36177676
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    Pharmaceutical Product Development Clinical Research Organization (CRO)
    Study date(s)
    July 2012 to November 2022
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Pregnant women containing sufficient evidence to confirm that exposure to commercially supplied belimumab occurred within the 4 months prior to and/or during pregnancy
    • Pregnant women with sufficient information to classify the pregnancy as prospective or retrospective (ie,whether the outcome of pregnancy was known at the time of first contact with the registry)
    • Reported cases that do not meet the minimum inclusion criteria for registry enrollment will be ineligible for inclusion in the registry
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Pregnant women containing sufficient evidence to confirm that exposure to commercially supplied belimumab occurred within the 4 months prior to and/or during pregnancy
    • Pregnant women with sufficient information to classify the pregnancy as prospective or retrospective (ie,whether the outcome of pregnancy was known at the time of first contact with the registry)
    • Pregnant women with full contact information to allow for follow-up (name, address, telephone number/email address) and contact information for applicable HCPs if initial reporter is the pregnant woman
    • Consent provided by the pregnant woman for her participation and assent for participation of her infant.
    Exclusion criteria:
    • Reported cases that do not meet the minimum inclusion criteria for registry enrollment will be ineligible for inclusion in the registry

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Duesseldorf, Germany, 40225
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Innsbruck, Austria, 6020
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Paris, France, 75651
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pisa, Italy, 56126
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tel Hashomer, Israel, 52621
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Almada, Portugal, 2805-267
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 14 Results

    Study documents

    Study report synopsis
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2022-11-11
    Actual study completion date
    2022-11-11

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Belimumab pregnancy registry/GlaxoSmithKline pregnancy registries
    Click here
    Access to clinical trial data by researchers
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